EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
Daiichi Sankyo Co. Ltd.’s trophoblast cell surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (dato-dxd), has been approved in Japan for treating adults with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
